Catalog Number 305181 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 2 bd¿ blunt fill needles with syringe caused coring to occur in the medication vial while drawing up propofol.The following information was provided by the initial reporter: "when the crna's are drawing up only propofol they are finding coring of the stopper in the syringe.At first this had happened with the myco 18 gauge blunt so we moved to the bd blunt and now the same issue has happened.".
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Event Description
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It was reported that 2 bd¿ blunt fill needles with syringe caused coring to occur in the medication vial while drawing up propofol.The following information was provided by the initial reporter: "when the crna's are drawing up only propofol they are finding coring of the stopper in the syringe.At first this had happened with the myco 18 gauge blunt so we moved to the bd blunt and now the same issue has happened.".
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Manufacturer Narrative
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H6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 305181 and lot number 2228065.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
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Search Alerts/Recalls
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